Kisqali(ribociclib) 说明书

[Indications of Kisqali(ribociclib)]
Kisqali(ribociclib), also known as LEE001, is a new drug developed by Novartis Pharmaceutical. It is used to treat postmenopausal women with hormone receptor (HR)- positive and human epidermal growth factor receptor 2(HER2)- negative advanced or metastatic breast cancer.

【 Kisqali(ribociclib) Specification 】
This product is a tablet, 600mg/63 tablets.

[How to take Kisqali(ribociclib)]
Please consult your exclusive pharmacist for dosage. The recommended initial dose: 600 mg orally (3 tablets, 200 mg/ tablet), once a day for 21 consecutive days, 7 days after withdrawal, letrozole 2.5mg for 28 consecutive days. Until the disease progresses or the intolerable toxicity stops.

[Side effects of Kisqali(ribociclib)]
The most common adverse reactions (≥20%, ARs) are neutropenia, nausea, fatigue, diarrhea, leukemia, alopecia, vomiting, constipation, headache and back pain. The most common grades 3-4 (> 2%) are neutropenia, leukemia, abnormal liver function, lymphocytes and vomiting.

Experimental design
The study enrolled 668 postmenopausal women with HR+, HER2- advanced or metastatic breast cancer, who had not received other treatment after the disease progressed. Randomly divided into two groups: the experimental group: 334 people were given Ribociclib+ Letrozole, and the control group: 334 people were given placebo+Letrozole.

Clinical data
PFS was not obtained in the experimental group, and it was 14.7 months in the control group. The objective remission rate in the experimental group was higher than that in the control group (52.7% vs 37.1%), and the OS was immature.

Clinical trials-ongoing
①Ribociclib combined with trastuzumab in the treatment of advanced breast cancer (NCT02657343)
This is a phase II clinical trial to study the efficacy, side effects and optimal dosage of Ribociclib combined with trastuzumab or trastuzumab alone in the treatment of breast cancer (metastasis in nearby tissues or lymph nodes or other places, HER2+).
Venue: Dana Farber Cancer Institute
Brigham and women’s hospital
②Ribociclib combined with hormone therapy for ER+/HER2- medium risk early breast cancer (NCT03081234).
This is an international, multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Ribociclib in patients with hormone receptor positive, her2 negative and medium-risk breast cancer.
Venue: Columbia University/Herbert Owen Cancer Center